PMA P030022S039
- Device
- REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P030022
- Supplement
- S039
- Product code
- MRA
- Decision date
- 2018-03-20
- Classification
- Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Approval order statement
- Approval for the updated physician and patient labeling based on post approval study data.
Current openFDA PMA Record#
- Device
- REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P030022
- Supplement
- S039
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2018-03-20
- Decision code
- APPR
- Date received
- 2016-09-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for the updated physician and patient labeling based on post approval study data.